MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9600TFX29A

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/22/2024

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.H3 other text : the valve was not returned for evaluation.

Event Description

As reported by a field clinical specialist (fcs), during a tavr procedure with a 29mm sapien 3 valve in the aortic position, a kink in 16f esheath plus occurred and the valve could not advance past right femoral artery.A valve strut did go through sheath material.Per additional information provided by the fcs, the initial reporter did not allege the edwards devices were deficient in any way.There were no abnormalities observed with the sheath during prep.The patient's body habitus was large and sheath had to make a steep dive to access artery.It is suspected that sheath was not parallel enough with vessel.The patient had low tortuosity, low calcification and 9.7mm mld.There was no difficulty inserting the sheath in the patient.There was resistance when inserting the delivery system into the sheath and they were unable to pass the femoral head.There were no withdrawal difficulties.The valve exited the sheath on the partially expandable portion and there was a bent strut visible through the sheath.Everything was removed as one unit.There was no harm to the patient.A new sheath, delivery system, and valve was prepped and implanted.

Manufacturer Narrative

A supplemental mdr is being submitted for additional information from a product investigation.The complaint for valve frame damage was confirmed based on provided imagery.A review of the dhr and lot history did not provide any indication that a manufacturing non-conformance contributed to the complaint event.A review of ifu/training materials revealed no deficiencies.The device was not returned for evaluation.As device was not returned, engineering was unable to perform any visual, functional, or dimensional analysis.A review of edwards lifesciences risk management documentation was performed for this case.Per review, no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.As reported, ''during a tavr procedure with a 29mm sapien 3 valve in the aortic position, the patients body habitus was very large.A kink in 16f esheath plus occurred and the valve could not advance past right femoral artery.A valve strut did go through sheath material'' and "the patient body habitus was large and sheath had to make a steep dive to access artery.It is suspected that sheath was not parallel enough with vessel.'' per training manual, ''insertion force can vary due to angle of insertion, thv size, vessel diameter, tortuosity and degree of calcification'' and ''if insertion force is high, consider slightly pulling back the sheath while advancing the thv/delivery system 1-2 cm.'' in this case, as noted, the patient had a large body, which required a steep insertion angle.It is possible that the sheath kinked during maneuvers performed to introduce the device at a steep insertion angle.Additionally, the patient's access vessels had presence of calcification and tortuosity.The presence of calcification and tortuosity can create challenging pathway during delivery system advancement, leading to resistance.Additional manipulation was likely applied to overcome the resistance caused by the kinked sheath and the difficult anatomy, and it is possible that this caused the valve frame to interact with the kinked sheath shaft during insertion, resulting in frame damage as reported and observed in imagery review.As such, available information suggests that patient factors (calcification, tortuosity) and/or procedural factors (steep insertion angle, kinked sheath, excessive device manipulation, high push force) may have contributed to the complaint event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is required.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 18778807
• MDR Text Key: 336316240
• Report Number: 2015691-2024-01325
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9600TFX29A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 04/03/2024
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1